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Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

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ClinicalTrials.gov Identifier: NCT00405171
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : October 28, 2010
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
University Hospital, Caen

Brief Summary:
Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.

Condition or disease Intervention/treatment Phase
HIV Infections Hypercholesterolemia Antiretroviral Therapy Drug: Nevirapine Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
Study Start Date : June 2003
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Decrease in LDL cholesterol between baseline and week 52


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
  • plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
  • Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD
  • Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors.

Exclusion Criteria:

  • Protease inhibitors use within the previous 6 months,
  • Prior exposure to nevirapine
  • Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
  • AST or ALT>1.25N if hepatitis virus B or C were positive
  • Fasting glycemia>1.26g/L,
  • Current CHD
  • Triglycerides>4.6 mmol/L
  • Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405171


Locations
France
Côte de Nacre University hospital
Caen, France, 14033
Sponsors and Collaborators
University Hospital, Caen
Boehringer Ingelheim
Investigators
Principal Investigator: Jean-Jacques Parienti, MD University Hospital, Caen
Study Chair: Renaud Verdon, MD, PhD Côte de Nacre

Publications of Results:
Other Publications:
ClinicalTrials.gov Identifier: NCT00405171     History of Changes
Other Study ID Numbers: SIROCCO
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: October 2010

Keywords provided by University Hospital, Caen:
Efavirenz
Nevirapine
Dyslipidemia
HIV

Additional relevant MeSH terms:
HIV Infections
Hypercholesterolemia
Dyslipidemias
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Efavirenz
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers
Anti-HIV Agents